Process Engineer
About the Role:
We are seeking a skilled Process Engineer to provide hands-on technical support for manufacturing and logistics operations. This role focuses on troubleshooting, optimizing, and maintaining process systems, including clean-in-place (CIP), steam-in-place (SIP), washing, and sterilization equipment. If you have a passion for biopharmaceutical processes and automation, we encourage you to apply.
Key Responsibilities:
- System Implementation: Design, select, and integrate new or upgraded equipment, processes, and automation systems to support manufacturing.
- Troubleshooting & Continuous Improvement: Diagnose technical challenges, pinpoint root causes, and recommend corrective/preventive measures.
- Process Optimization: Drive enhancements to existing processes through data analysis and innovative problem-solving.
- Equipment Documentation: Develop and update operational and maintenance documentation, including training materials.
- Regulatory & Compliance Support: Assist in audits, inspections, and validation activities to ensure regulatory compliance.
- Collaboration: Work with cross-functional teams to support project execution and process enhancements.
- On-Call Support: Provide 24/7 technical support as needed to maintain operations.
Preferred Qualifications:
- Ability to navigate and work within CNC spaces, ISO-classified environments, and grey spaces.
- Fundamental knowledge of biopharmaceutical production equipment, including:
- Upstream: Incubators, Bioreactors, Centrifuges, Pasteurizers.
- Downstream: Chromatography columns, Viral inactivation, Ultrafiltration, Diafiltration, Freeze/thaw systems.
- Basic understanding of PLC systems, HMIs, and data historians.
- Strong understanding of engineering principles (fluid dynamics, heat transfer, etc.).
- Experience with cleaning and sterilization of process vessels and transfer lines.
- Ability to analyze process data (temperatures, pressures, valve sequencing) to troubleshoot equipment issues.
- Knowledge of regulatory compliance and audit preparation.
- Proficiency in Microsoft Office and other relevant software.
- Must be able to work onsite in Frederick, MD.
Why Join Us?
- Exciting opportunities for career growth in a fast-paced environment.
- Competitive pay and performance incentives.
- Comprehensive health, dental, and vision insurance.
- Company-paid life, short-term, and long-term disability insurance.
- Flexible spending accounts (FSA, DCARE, commuter benefits).
- 401(k) retirement plan with employer matching.
- Paid time off, holidays, and as-needed sick time.
- Tuition reimbursement for career development.
- Team events, employee recognition programs, and referral bonuses.
- Paid parental leave and bereavement support.
